Structured vs Self-Guided Multidomain Lifestyle Interventions for Global Cognitive Function: The US POINTER Randomized Clinical Trial.

Background

To compare the effects of two 2-year lifestyle interventions on cognitive trajectory in older adults at risk of cognitive decline and dementia.

比较两种为期两年的生活方式干预措施对有认知衰退和痴呆风险的老年人认知轨迹的影响。

DESIGN, SETTING, AND PARTICIPANTS: Single-blind, multicenter randomized clinical trial enrolling 2111 participants from May 2019 to March 2023 (final follow-up, May 14, 2025) at 5 clinical sites in the US.

设计、设置和参与者：单盲、多中心随机临床试验，从2019年5月到2023年3月（最终随访，2025年5月14日）在美国的5个临床中心招募了2111名参与者。

Participant inclusion criteria enriched risk of cognitive decline and included age 60 to 79 years, sedentary lifestyle, and suboptimal diet plus at least 2 additional criteria related to family history of memory impairment, cardiometabolic risk, race and ethnicity, older age, and sex.

参与者纳入标准包括认知衰退的高风险，并包括年龄在60至79岁之间、久坐不动的生活方式、饮食不佳，以及至少满足与记忆障碍家族史、心代谢风险、种族和民族、年龄较大和性别相关的2个额外标准。

Methods

Participants were randomly assigned with equal probability to structured (n = 1056) or self-guided (n = 1055) interventions.

参与者以等概率随机分配到结构化(n = 1056)或自我引导(n = 1055)干预组。

Both interventions encouraged increased physical and cognitive activity, healthy diet, social engagement, and cardiovascular health monitoring, but differed in structure, intensity, and accountability.

两种干预措施都鼓励增加身体和认知活动、健康饮食、社交参与和心血管健康监测，但在结构、强度和责任性方面有所不同。

main_outcomes_and_measures

The primary comparison was difference between intervention groups in annual rate of change in global cognitive function, assessed by a composite measure of executive function, episodic memory, and processing speed, over 2 years.

主要比较的是干预组之间在2年内通过执行功能、情景记忆和处理速度的综合测量评估的全球认知功能年变化率的差异。

Results

Among the 2111 individuals enrolled (mean age, 68.2 [SD, 5.2] years; 1455 [68.9%] female), 89% completed the year 2 assessment.

在纳入的2111名个体中（平均年龄68.2岁，标准差5.2岁；1455名[68.9%]为女性），有89%的人完成了2年的评估。

The mean global cognitive composite z score increased from baseline over time in both groups, with a mean rate of increase per year of 0.243 SD (95% CI, 0.227-0.258) for the structured intervention and 0.213 SD (95% CI, 0.198-0.229) for the self-guided intervention.

两组的平均全球认知综合z分数随时间从基线开始增加，结构化干预的平均每年增加速率为0.243个标准差（95%置信区间，0.227-0.258），自我引导干预的平均每年增加速率为0.213个标准差（95%置信区间，0.198-0.229）。

The mean rate of increase per year was statistically significantly greater for the structured group than the self-guided group by 0.029 SD (95% CI, 0.008-0.050; P = .008).

与自我引导组相比，结构化组的平均每年增加速率在统计学上显著更高，高出0.029个标准差（95%置信区间，0.008-0.050；P = .008）。

Based on prespecified secondary subgroup comparisons, the structured intervention benefit was consistent for APOE ε4 carriers and noncarriers (P = .95 for interaction) but appeared greater for adults with lower vs higher baseline cognition (P = .02 for interaction).

基于预先设定的次要亚组比较，结构化干预对APOE ε4携带者和非携带者的益处是一致的（交互作用P = .95），但对于基线认知能力较低的成年人似乎比基线认知能力较高的成年人更大（交互作用P = .02）。

Fewer ascertained adverse events were reported in the structured group (serious: 151; nonserious: 1091) vs the self-guided group (serious: 190; nonserious: 1225), with a positive COVID-19 test result being the most common adverse eventoverall and more frequent in the structured group.

在结构化组中报告的确定的不良事件较少（严重：151例；非严重：1091例），与自我指导组（严重：190例；非严重：1225例）相比，其中COVID-19阳性检测结果是最常见的不良事件，并且在结构化组中更为频繁。

conclusions_and_relevance

Among older adults at risk of cognitive decline and dementia, a structured, higher-intensity intervention had a statistically significant greater benefit on global cognition compared with an unstructured, self-guided intervention.

在有认知衰退和痴呆风险的老年人中，结构化、高强度的干预措施与非结构化、自我引导的干预措施相比，在全球认知功能上有统计学上显著更大的益处。

Further investigation of functional outcomes, biomarkers, and ongoing extended follow-up will help address clinical relevance and sustainability of the observed cognitive benefits.

进一步研究功能结果、生物标志物以及持续的长期随访将有助于解决观察到的认知益处的临床相关性和可持续性问题。

trial_registration

ClinicalTrials.gov Identifier: NCT03688126.

临床试验注册号：NCT03688126。